Device for treating an individual suffering from cardiac insufficiency, cardiac arrest, circulatory arrest or stroke

ABSTRACT

The invention relates to a device for treating an individual suffering from cardiac or circulatory arrest or from a stroke, comprising blood withdrawal means (BE) that can be applied to the individual (P), an analysis unit (BA) directly or indirectly connected to the blood withdrawal means for detecting and providing, in the form of a blood analysis result (BAE), at least one characteristic of the blood, directly or indirectly connected to a return means (BR) that can be applied to the individual (P) and is designed to deliver a substance to the individual via the return means (BR).

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to a device for treating an individual sufferingfrom cardiac insufficiency, cardiac arrest, circulatory arrest orstroke.

2. Description of the Prior Art

Given the current level of knowledge and the current therapeuticmethods, individuals, more particularly patients, who have sufferedcardiac arrest, can only be resuscitated without damage to the brain orthe heart functions if cardiopulmonary resuscitation is successfullycarried out within a period of three to five minutes after the cardiacarrest has occurred. Resuscitation carried out with a further time delayinevitably leads to severe cerebral damage due to reperfusion withnormal blood which causes massive damage to the ischaemic tissue.

Ischaemic and reperfusion modifications in tissues mainly play a centralrole in heart surgery. For example mycocardial ischaemia is eitherinduced by the surgeon himself, for instance as part of global ischaemiathrough aortic clamping, or also during a heart transplant and/orregionally in “off-pump surgery” for application of a coronary by-pass.However, emergency operations are also performed on patients withmyocardial ischaemia who, for example, are suffering from cardiogenicshock, acute coronary occlusion or a condition immediately afterresuscitation. For these reasons heart surgeons have been intensivelyoccupied with ischaemia and reperfusion phenomena for decades.

In accordance with current knowledge, it can be assumed that ischaemia,even long-lasting ischaemia, only causes relatively small structuraldamage to the heart muscle. However, if after such an ischaemic attackthe myocardium is reperfused with normal blood under “physiological”conditions, an additional damaging mechanism occurs explosively, whichin the meantime has been well researched as “reperfusion damage”. Onreperfusion of an ischaemically damaged myocardium with normal blood,processes suddenly occur which can definitively destroy the alreadydamaged tissue.

To prevent or completely hinder the reperfusion damage occurring throughreperfusion with normal blood, concepts have been developed which afterrevascularization initially endeavour to treat the ischaemically damagedmyocardium, whereby both the composition of the initial reperfusate andthe conditions of the initial perfusion are aimed at treating the damageoccurring during the ischaemia and/or ruling out possibly occurringreperfusion damage right from the start.

The concept of controlled reperfusion is based on the one hand onmodifying the initial reperfusate differently from the body's own bloodas well as modifying the conditions of the initial reperfusion.

In connection with this, DE 696 31 046 T2 discloses a device fortreating a patient with cardiac arrest which uses the known method ofselective aortic arch perfusion, SAAP in short, in which in order tocarry out relatively isolated perfusion of the heart and brain, aballoon occlusion catheter is applied, usually via the patient's femoralartery, to the location of the descending aortic arch and then dilated,after which an oxygenated blood substitute solution, for exampleperfluorocarbon emulsion or a polymerized haemoglobin solution is theninfused via the lumen of the SAAP catheter. The blood substitutesolution, also known as a protective solution, is administeredintracorporeally using a pulsing device with a pulsating rhythm. In avariant embodiment the known device has a blood withdrawal means, withwhich blood can be withdrawn from the patient which is taken to bloodoxygenation means for oxygenation and, together with a protectivesolution added to the oxygenated blood, is infused into the patient viablood return means. It should be noted here that to carry out selectiveaortic arch perfusion and thus to use the above device, a surgicalprocedure and the associated clinical infrastructure are necessary.

U.S. Pat. No. 5,195,942 discloses a comparable procedure forresuscitating a person, in which by inflating a balloon catheter in theregion of the ascending aorta in order to increase the blood flow intothe coronary arteries, a blood-compatible, oxygen liquid is injected forflowing on into the coronary arteries.

U.S. Pat. No. 7,387,798 B2 describes a method for the resuscitation ofpatients suffering from cardiac arrest, in which a liquor fluid is takenfrom the subarachnoid area of the patient's central nervous system. Anartificially composed cerebrospinal fluid containing a large number ofcomponents, such as sodium, potassium, calcium, magnesium, water,polypeptides, insulin and ATP, is then infused, whereupon conventionalcardiopulmonary resuscitation is carried out

For resuscitating a patient or an animal, U.S. Pat. No. 5,416,078discloses administering a solution of Deferoxamine with water-solublebiopolymers to the patient to be treated.

WO 94/21195 describes administering an A3 adenosine receptor agonist forpreparing the organ in order to protect it against ischaemic damage.

In EP 1 021 084 B1 a method of eliminating or reducing ischaemic damageto an organ is set out. Here, the damaged organ is rinsed with abuffered physiological solution in order to remove acidic products whichhave accumulated in the organ during the period of oxygen deficiency.

U.S. Published Application 2005/0101907 A1 describes an automatic systemfor the resuscitation of a patient in which a single fluid is infused inrelation to the fluid inflow as function of physiological parameters ofthe patient.

A comparable automatic infusion system for treating trauma patients isdisclosed in U.S. Pat. No. 5,938,636, for infusion of an administeredfluid into the patient with the infusion pressure and infusion flowbeing sensor-recorded and computer-monitored.

DE 10 2008 024 471 A1 describes a heart-lung by-pass device which can beconnected to a patient by one tube to the arterial and one tube to thevenous blood vessel system. Extracorporeally, between the tubes, thereis a blood flow line along which bi-directionally operating pumps and afluid reservoir can be provided. Controllable fluid control valvesfitted with sensors are also arranged along the blood flow line. Throughbi-directional pump operation, the lungs assume the function of theoxygenators of the heart-lung by-pass device.

U.S. Pat. No. 5,308,320 describes a portable resuscitation device forcardiac arrest patients having blood withdrawal means, a pump for movingthe blood within the devices, means for oxygenating the blood and meansfor returning the oxygen-enriched blood back into the blood circulation.

SUMMARY OF THE INVENTION

The invention is a device for providing full resuscitation of a patientwithout the risk of ischaemic damage during a period of time between theonset of the cardiac arrest and the initiation of resuscitation measureswhich is considerably greater than the previous critical time window of3 to 5 minutes. The device allows as fully automatic resuscitation aspossible so that no complicated therapeutic precautions have to be takenin situ. The device also is lightweight and portable and independentlyoperable as possible so that it can be used as an instrument foremergency medicine on site. The device is useful for a cardiac arrest,and for cardiac insufficiency or a stroke, based on the same principles.

The invention exerts, by way of at least one sensor-supported bloodanalysis of the individual's blood, an individual bloodanalysis-dependent influence on the blood taken from the individual sothat an individually selected substance or an individually producedsubstance mixture is added or mixed to the blood taken from theindividual to obtain “modified blood.” The thus obtained “modifiedblood” is reperfused into the individual as a reperfusate with the goalof partially or fully preventing the ischaemic tissue damage otherwiseoccurring on activation of the natural or artificially-supported bloodcirculation system or on initial blood supply to areas of tissuedisconnected from the natural blood circulation for a shorter or longerperiod.

The device in accordance with the invention for treating an individualwith cardiac arrest or stroke, includes blood withdrawal meansattachable to the individual for withdrawing at least part of the bloodfrom an individual, an analysis unit directly or indirectly connected tothe blood withdrawal means for recording and providing at least oneproperty of the blood in the form of blood analysis result, an operativeunit, which is indirectly or directly connected to return meansattachable to the individual and designed to administer a substance tothe individual via the return means. The operative unit has at least onereservoir in which at least two substances are stored. The reservoirunit is combined with a dosage unit, which, taking into consideration ablood analysis result determined by the analysis unit, selects at leastone of the two substances or prepares a mixtures of at least two of thesubstance. The at least one selected substance or the mixture can thenbe applied to the individual directly or indirectly via the returnmeans.

The individual is, more particularly, a human or animal patient. Theterms “patient” and “individual” are used synonymously here. Cardiacinsufficiency is understood, for example, as a traumatic or pathologicalreduction in the output of the heart, which may be caused by a heartattack, cardiogenic shock or heart failure.

In one variant, the device of the invention also has a sensor device,recording at least one property of the individual's blood, whichgenerates a sensor signal, which is then evaluated by the analysis unitand made available as a blood analysis. The analysis unit isfundamentally suitable for working with the sensor unit so that a sensorsignal determined/generated by the sensor unit can be transmitted fromthe sensor unit to the analysis unit. The device can be produced withalready known sensors.

The sensor unit can comprise a plurality of sensors, of which eachsensor records at least one parameter or property of the blood.

In one variant, the sensor unit is designed as a non-invasive componentwhich can be directly or indirectly attached to the individual.

The withdrawal means for taking the blood are envisaged and set up towithdraw at least part of the blood from an individual before the bloodis influenced by the operative unit. For this the withdrawal means are,for example, invasively attachable to the individual. In this way atleast two litres, more particularly at least three litres, moreparticularly at least four litres, more particularly all the blood inthe individual's blood vessels, can be withdrawn.

Through the also provided return means, the withdrawn and treated orinfluenced blood, that is the “modified blood,” can be returned into thebody of the individual. The return means can also be invasively attachedto the individual.

On the one hand, at least one substance in the form of an additive tothe blood in the patient, for example, can be administered by way of aninjection into the infusion, or the patient's blood is removed from thepatient by way of withdrawal means and extracorporeally enriched ortreated with the at least one substance which is then reperfused intothe patient in the form of “modified blood.” It is also conceivable toremove essentially all the blood from a patient and, instead of thisblood, to return the “modified blood” or a solution, individuallyadapted to the patient and containing at least one substance, directlyto the patient in order to then be able to initiate the process ofresuscitation without tissue damage.

In one embodiment, the sensor unit is directly or directly connected tothe withdrawal means.

For the purpose of modification and/or manipulation of the patient's ownblood individually adapted to the patient situation, in one variant theoperative unit is controlled or regulated by an evaluation and controlunit on the basis of the analysis result which represents the patient'scurrent condition.

Advantageously, the analysis unit, the operative unit and the evaluationand control unit are designed as a portable and standard unit, in whichthe sensor unit is preferably part of the standard unit.

The sensor unit generates the sensor signal which represents the atleast one property of the blood taken from the patient and can betransmitted by cable or wirelessly to the analysis unit, whereby on thebasis of the analysis results, the evaluation and control unit generatescontrol or regulating signals. These can be used, for example, to selector dose the type and/or quantity the substance or substance mixture tobe added. Here, the sensor unit records at least one of the followingparameters: pH value, partial oxygen pressure (pO₂), partial carbondioxide pressure (pCO₂), potassium content (K), sodium content (Na),calcium content (Ca), base excess (BE), lactate value (La) and glucosecontent (Gu).

The device in accordance with the invention is preferably also designedas a portable and easy to operate, more particularly as a fullyautonomous unit, so that it is not necessarily exclusively usable bymedical specialist personnel. One form of embodiment comprises aportable handy unit, from which only two tubes extend, which on thepatient side are connected to the blood vessel system. One tube is fortaking the blood from the patient, via which the patient's bloodautomatically flows out into the unit, in which an analysis of the bloodand corresponding modification of the blood take place. Theappropriately “modified blood” is then reperfused into the patient viathe other tube. Alternatively, this device also makes it possible,before the “modified blood” is returned to the patient, to administer tothe patient an individually composed perfusion solution, the compositionof which depends on the result of the analysis of the patient's ownblood. For a successful treatment outcome, it is therefore conceivablein a first step to largely substitute the blood with an individuallycomposed perfusion solution. Only later on during the treatment is theaforementioned “modified blood” administered, possibly aftersuccessfully carrying out further resuscitation measures.

In one variant the operative unit is intended and designed to dispensethe at least one substance to the individual or the blood in dosed format the correct temperature and/or pressure.

Preferably, a monitoring unit is provided which has at least onemeasuring means for recording the at least one parameter of theindividual, which is selected from the group of physiological parametersof the individual, comprising mean arterial pressure, central nervouspressure, pulmonary arterial pressure, oxygen saturation and bloodtemperature, whereby the monitoring unit is connected to an evaluationand monitoring device for at least unilateral data exchange.

Fundamentally, the blood is taken from the patient as a bodily fluid.However, the embodiments of the device relating to blood as the bodilyfluid can also be used for other bodily fluids in an analogous manner.

The blood withdrawal means to be applied to the patient is preferablyconnected via a blood flow path, in the simplest case in the form of ahollow tube, to the blood return means applicable to the patient,whereby, more particularly, along the blood flow path the reservoir unitof the operative unit is provided, which contains at least twosubstances, and from which at least one of the substances to be selectedor a substance mixture can be added to the blood flow path or the returnmeans.

Along the blood flow path a heat exchanger unit can also be providedwhich is directly or indirectly connected to the return means. At leastone conveying means integrated along the blood flow path is also foradjusting the blood flow along the blood flow path in order to assuresimple transporting of the blood from the individual's body and of themodified blood into the individual's body. Preferably, for returning theblood to the body a further, separate conveying means is provided, withwhich flow characteristics can be set which are individual and above allindependent in terms of pulsability, flow pressure and speed.

For controlling all present conveying means as well as the heatexchanger unit, the evaluation and control unit generates furthersignals, so that ultimately the flow pressure, the flow rate and/ortemperature of the at least one substance or the “modified blood” to bereturned to the patient can be set in a predetermined manner.

The analysis unit with its sensor unit is also arranged along the bloodflow path, so that in terms of individual blood parameters, moreparticularly a large number of blood parameters, the blood can beanalyzed and a blood analysis result made available for furtherevaluation. The analysis preferably takes place online, that is on site,while the blood is being taken from the patient by the blood withdrawalmeans.

Taking into consideration the blood analysis result determined by theanalysis unit, the dosage unit connected to the reservoir unit brings apredeterminable quantity of the at least one substance from thereservoir unit and adds it into the blood flow path or the return means.This means that with the aid of the dosage unit an individually composedreperfusate based on the current condition of the patient to be treatedis produced, which is then reperfused into the patient via the appliedblood return means.

Particularly in the reperfusion of “modified blood” into the patient,but also in the simple administration of a perfusion fluid, the additionof at least one, more particularly many substances to the patient's ownblood or the perfusion solution as well as the perfusion itself, takesplace, with regard to the selection of the reperfusion pressure, theflow rate, the reperfusion duration and the temperature of thereperfusate, taking in consideration and adapted to the patient'scurrent sensor-recorded blood picture. The aforementioned monitor unitcan be used for this for example. In this way the selection and settingof the physiological reperfusion conditions can also take place takinginto consideration the physiological parameters determined by themonitoring unit.

The aforementioned evaluation and control unit, which can, for example,be connected both to the analysis unit and to the dosage unit for thepurpose of at least unilateral data exchange, is used to evaluate bloodanalysis results determined by the analysis unit and to determine thetype and quantity of the substances to be added to the patient's ownblood or the perfusion solution. The blood analysis result is evaluatedin the evaluation and control unit under predetermined evaluationcriteria, which can also take the physiological patient parametersrecorded by the monitoring unit into consideration.

Data transmission connections in the form of conventional datatransmission cables or wireless technologies are used for the at leastunilateral exchange of data.

As a result of the evaluation of the blood analysis result, theevaluation and control unit generates control signals which aretransmitted to the dosage unit for selecting the type and quantity ofthe substances to be added to the blood flow. In connection with this,the term “dosage unit” is understood as a technical means with which itis possible, from a number of substances stored in separate reservoirchambers, on the basis of defined mixing plan in which the selection ofthe relevant substances and the quantity of the substance to be added isdefined, to make a mixture which is ultimately to be added to thepatient's own blood. It is not necessary to premix the selectedsubstances before adding them to the patient's own blood as theseparate, dosable addition of individually selected substances to theblood flow path is also conceivable.

Preferably. the dosage unit has at least one mixing container, which hasindividually controllable dosing means which are connected to theindividual reservoir chambers. In the mixing container, a substancemixture to be added to the bodily fluid of the individual is produced inthe mixing container in the form of a solution, a suspension or anemulsion. Thus, the substances stored in the reservoir chambers are notnecessarily fluid and an individual substance can also be present insolid or powder form or also in the gaseous phase. For example, thefollowing substances or substance classes from which an individualselection can be made to produce a substance mixture to be added to thebodily fluid of the individual can be stored in the individual reservoirchambers: alkaline or acidic buffer solution, substances affecting thesodium, potassium and/or calcium content, blood-thinning substances,free radical trapping agents, glutamate, aspartame,heart-rhythm-stabilizing substances (Lidocaine), substances influencingthe leukocyte count, osmotically-active substances, namely salts,glucoses, proteins.

In one variant, a filter unit for blood filtering is provided along ablood flow path between the blood withdrawal means and the return means.This filter may include a leukocyte filter for example.

In one variant along the blood flow path between the blood withdrawalmeans and the return means, directly upstream of the return means aby-pass line is provided, through which some of the “modified blood” tobe returned to the individual can be supplied to the analysis unit andin the event of an anomalous nominal/actual comparison, the dosage unitchanges the quantity of the at least one substance supplied into theblood path flow for at least one determinable blood parameter.

In one variant, the individual components of the device are so compactand light in weight that the device is portable.

In one variant, along a blood flow path between the blood withdrawalmeans and the return means, an oxygenation and oxygen-depletion unit forthe blood is provided in order to match the oxygen content of themodified blood to be returned to the relevant requirements.

One form of embodiment of the device in accordance with the inventionincludes a portable base module, hereinafter referred to as GIRD (asacronym for Controlled Integrated Resuscitation Device. The CIRD basemodule has an extracorporeal blood flow path which can be applied by wayof suitable blood withdrawal and (blood) return means to the patient'sblood circulation, more particularly in the area of the femoral arteryand femoral vein. Along the extracorporeal blood flow path, the CIRDbase module has a conveying means for maintaining the blood flow, anoxygenator for enriching the blood with oxygen, as well as a device forCO₂ depletion and finally, a leukocyte filter, and can be modularlyexpanded with the aforementioned blood analysis unit as well as thepreviously described reservoir and dosing unit.

With the aid of such a device, for the automatic operation and controlof which the also previously mentioned evaluation and control unit isprovided, mostly in the form of a computer unit, it is possible toquickly and automatically analyze the blood taken from a patientsuffering from cardiac arrest and to determine exactly which compositionof additional substances has to be added to the patient's own blood.From the result of the blood analysis, and, possibly, also taking intoaccount the sensor-recorded physiological parameters of the patient, areperfusate is finally automatically produced which is individuallyadapted to the patient and introduced into the patient under optimizedconditions in terms of pulsability, flow pressure, flow rate and/ortemperature. This creates ideal conditions for the initial perfusion interms of the reperfusion pressure, the reperfusion flow and thereperfusion duration.

As the device in accordance with the invention allows continuousmonitoring of the patient's own blood, the reperfusion conditions andthe composition of the reperfusate can be adapted in situ or online,that is continuously, to the current condition of the patient beingreperfused. More particularly, through the in situ/online measurement ofcertain blood parameters, such as the concentration of potassium ions,lactate, glucose or the pH value etc. as well as through the combinedmeasurement of haemodynamic parameters by way of suitable monitoringsensors which record the flow resistance, temperature, the flow rate aswell as the flow pressure etc. within the blood flow path, automaticadjustments can be made as part of the controlled whole-bodyreperfusion.

The device in accordance with the invention for extracorporealwhole-body reperfusion was successfully tested in experiments on pigs.Fifteen minutes after controlled induced cardiac arrest in normothermicconditions, animals could be successfully resuscitated withoutnoticeable or measurable organ damage or neurological damage. Theseexperiments show, for the first time. that it is possible to achievefully functional neurological recovery, even 15 minutes after the onsetof cardiac arrest, a fact which is in sharp contrast to the model andlimitations of current conventional treatments. More particularly,through the lightweight and portable design of the device in accordancewith the invention, completely new perspectives are opened up foremergency medicine which could result in very many patients, who todayhave no chance of resuscitation and/or full recovery, not only beingable to be saved in future, but also to recover without neurologicaldamage.

The subject matter of the invention is also a method of treating anindividual suffering from cardiac arrest or stroke in which blood istaken from the individual which then undergoes a blood analysis, wherebytaking into consideration a blood analysis result determined by theanalysis unit and at least one evaluation criterion, from at least twostored substances the type and quantity of at least one of thesubstances or a substance mixture are determined, which in dosed form isadded to the removed blood to obtain “modified blood” which isreperfused into the individual or which is reperfused into theindividual in the form of perfusion solution in place of the removedblood.

In one variant of the method of the invention, the blood is taken fromthe individual before recording the properties and returned after addingthe at least one selected substance to the blood.

In one variant, the recording, evaluation and influencing take place ina closed control cycle.

In one variant of the method of the invention, the analysis result iscompared with a nominal value, and in the event of a quantitativelypredeterminable deviation from the nominal value, a substanceinfluencing the blood property forming the basis of the analysis resultis selected and introduced into the individual or the blood in aquantity depending on the quantitative deviation.

In one variant of the method of the invention, at least two litres, moreparticularly at least three litres, more particularly at least fourlitres, more particularly all the blood in the individual's bloodvessels, is to be withdrawn before reperfusion of the modified bloodtakes place.

In one variant of the method of the invention, the blood is taken fromthe patient over a period of 10 seconds to 3 minutes, more particularly20 seconds to 2 minutes, more particularly 30 seconds to 1 minute.

In one variant of the method of the invention, some of the “modifiedblood” is branched off for the purpose of repeated blood analysis, andif the at least one determined blood parameter deviates from the nominalvalue, a correction to the type and/or quantity of the at least oneadded substance takes place.

In one variant of the method of the invention, the procedures of takingthe blood, blood analysis, adding the at least one substance to theblood or perfusion solution as well as the reperfusion of the modifiedblood or perfusion solution take place in situ.

In one variant of the method, in addition to the blood analysis, atleast one physiological parameter of the individual is determined.Taking into consideration both the blood analysis result and also the atleast one physiological parameter of the individual, the type andquantity of the at least one substance to be added to the removed bloodor perfusion solution, as well as the pressure, flow rate andtemperature of a modified blood flow or solution to be reperfused intothe individual, are selected.

In one variant of the method of the invention, the reperfusion of the“modified blood” or perfusion solution into the individual takes placeat least two different parts of the body each with different reperfusionparameters in terms of pressure, flow rate, temperature and/orreperfusion duration.

In one variant of the method of the invention, the blood is taken at acontrolled flow rate of at least 1 l/min, more particularly from 6 to 8l/min.

All the above-mentioned method variants can be combined with each otherin any way and order.

BRIEF DESCRIPTION OF THE INVENTION

The invention is described below, without restricting the generalconcept of the invention, by way of examples of embodiments withreference to the drawings, in which

FIG. 1 shows a block diagram of an illustration of the individualcomponents of an example of embodiment;

FIG. 2 shows a schematic view of the analysis unit;

FIG. 3 shows a schematic view of a reservoir and dosage unit; and

FIG. 4 a generalized block diagram of an example of embodiment.

DESCRIPTION OF EMBODIMENTS OF THE INVENTION

In FIG. 1, a block diagram for illustrating all the components of a formof embodiment of a device in accordance with the invention is shown. Theuse of the device is explained in more detail using the example of ahuman patient P as an individual who has suffered a cardiac arrest.Applied to the patient P in the area of femoral vein in order take bloodare blood withdrawal means BE, from which a blood flow path BL extendsextracorporeally, which passes through various technical components andfrom which at various points lines branch off and into which at variouspoints lines open, which are discussed in more detail below. Finally theblood flow path BL enters the patient again, more particularly in thearea of the femoral artery to which a blood returns means BR are alsoapplied.

For controlled blood withdrawal from the patient P and for setting thereperfusion parameters under which the device to be described returns“modified blood” or reperfusate into the patient's blood circulation, aconveying means LF is provided along the blood flow path BL, which ismore particularly in the form of a centrifugal pump and is to be seen asa component of the lightweight and portable CIRD. The conveying means LFcan also be variably adjusted in terms of conveying output, conveyingcharacteristics and duration, that is pressure, duration andpulsability, via an evaluation and control unit A/S yet to be describedin more detail. In addition, the portable CIRD has an oxygenator O, withwhich the blood taken from the patient is enriched with oxygen. Incertain cases, with the aid of the oxygenator, it is also possible todeplete oxygen from the patient's own blood. There is also a gas blenderG, which influences the blood CO₂ content, usually in the form ofdepletion of the CO₂ content in the patient's own blood. For individualtemperature control of the blood flow within the blood flow path BL, theoxygenator O is also connected to a heat exchanger unit. The heatexchanging characteristics are influenced in a controlled manner by theevaluation and control unit A/S. Finally, the portable CIRD unitcomprises a leukocyte filter through which the leukocyte content of thepatient's blood can be influenced.

A first by-pass lien A1 is provided in the blood flow path BL directlyleaving the patient, via which some of the patient's blood is branchedoff into an analysis unit BA in which the patient's blood is analyzed bysensors with respect to various blood parameters.

In an expanded form of embodiment, the device of FIG. 1 may besupplemented with further functional units, which are able to modify ormanipulate the patient's blood in the following manner.

Means are thus provided for influencing the patient's blood throughextracorporeal pressure exertion on the patient in such a way that interms of time and space the pressure exertion takes place in apredeterminable manner on the patient evenly or selectively. Such meansfor the mechanical influencing of the patient's blood can alternativelyalso be applied invasively and for intracorporeal pressure exertion onthe patient's blood.

In addition, means for the thermal influencing of the patient's bloodfor extracorporeal temperature control can be provided and designed sothat in terms of time and space, the temperature control takes place ina predeterminable manner on the patient evenly or selectively. Suchmeans for the thermal influencing of the patient's blood canalternatively also be applied invasively and for intracorporealtemperature control of the patient's blood so that in terms of space andtime the temperature control takes place in a predeterminable mannerwithin the patient evenly or selectively.

Preferably, to return the blood to the body of the patient P, along theblood flow path, before or after the leukocyte filter LF at least onefurther, separate conveying means (not shown) can be provided, withwhich conveying characteristics can be set which are individual andabove all independent in relation to pulsability, flow pressure andspeed.

In FIG. 2, an analysis unit BA is shown schematically for more detailedexplanation. It is assumed that via line A1, part of the patient's bloodwill reach the blood analyzing analysis unit BA. Within the analysisunit BA, more particularly in the form of a sensor unit, a number ofindividual sensors SE₁ to SE_(n) are provided, which analyze the bloodwith regard to various blood parameters. Advantageously brought togetherin the analysis/sensor unit are known sensors each one of which is ableto record at least one of the following non-exhaustively listedparameters: pH-value, partial oxygen pressure (pO₂), partial carbondioxide pressure (pCO₂), potassium content (K), sodium content (NA),calcium content (Ca), the base deviation designated as BE, also known asbase excess/base deficit with which metabolic disorders of the acid-basebalance can be detected, lactate value (La), glucose content (Gu) toname but a few.

Each individual sensor SE_(1 . . . n) determines one blood parameterSEE_(1 . . . n), characteristic of the patient's blood, which togetherproduce the so-called blood analysis result BAE which reflects thecurrent quality of the patient's own blood. More particularly, the bloodanalysis result is transmitted via a data transmission cable to theevaluation and control unit A/S in which the blood analysis result BAEundergoes separate analysis and evaluation based on medical evaluationcriteria.

The purpose of the device in accordance with the invention is ultimatelyto transform, through the addition of certain substances, the patient'sblood into a modified state which can be characterized in the fact thatthe specially “modified blood” or the reperfusate should not cause anytissue damage during initial reperfusion into the patient for thepurpose of the patient's resuscitation. In addition, it intended toreduce/heal ischaemic damage which may have already occurred in certaintissue areas.

Within the evaluation and control unit A/S the current sensor-recordedindividual blood parameters SEE_(1 . . . n) of the patient's blood arecompared with blood parameter-specific references or nominal values,which are to be restored through modification of the patient's blood. Inaccordance with such an evaluation the type and quantity of the relevantsubstances to be added to the patient's blood are determined. Theevaluation/control unit is in informal communication with a reservoirunit R as well as a dosage unit D combined therewith, which are bothshown schematically in FIG. 3. In accordance with FIG. 3 the reservoirunit R comprises four individual reservoir chambers in which fourdifferent substances S₁, S₂, S₃ and S₄ are stored. More such reservoirchambers can of course be provided, that is in general reservoirchambers for storing n different substances. The individual reservoirsare each connected to a mixing container MB, whereby along theconnection lines dosage means in the form of stop valves V₁, V₂, V₃ andV₄ are provided. Depending on the current blood analysis result BAE andthe additive requirement determined by the evaluation/control unit forthe substance to be mixed to the patient's blood, the evaluation/controlunit generates control signals Si₁, Si₂, Si₃, Si₄ for operating thedosage means V₁ to V₄. Finally, the mixture of the individual substanceprepared in the mixing container MB is introduced into the blood flowpath BL.

In a variant a monitoring unit M, see FIG. 1, is provided, which viasensors applied to the patient P, records physiological patientparameters, for example the mean arterial pressure, the central venouspressure, the pulmonary arterial pressure, oxygen saturation, as well asbody temperature, to name but a few. The physiological patent parametersare also transmitted by the monitoring unit M to the evaluation andcontrol unit A/S, where after being taken into consideration theevaluation and control unit generates the control signals for the dosageunit.

Before the reperfusate is returned to the patient P via the blood flowpath BL, with the aid of the analysis unit BA, an analysis of the“modified blood”/reperfusate is carried out to ensure that a correctlycomposed/modified reperfusate is being returned to the patient. Forthis, a second by-pass line A2 is provided immediately upstream of theblood return means BR which diverts some of the “modifiedblood”/reperfusate into the analysis unit BA. In the analysis unit BA,repeat sensor recording of the individual blood parametersSEE_(1 . . . n) takes place, which undergo a nominal/actual comparisonin the evaluation and control unit A/S. If deviations occur, thegenerated control signals Si₁, Si₂, Si₃, Si₄ are corrected in orderinfluence the dosage means V₁ to V₄.

Furthermore, on the basis of the blood analysis results BAE and thephysiological patient parameters determined by the monitoring unit M,the evaluation and control unit generates control signals to control theconveying means LF determining the flow characteristics within the bloodflow path BL, as well as the heat exchanger WT determining thetemperature level of the reperfusate being infused into the patient,ultimately with the aim of tissue-protecting reperfusion of the“modified blood” back into the patient's blood circulation. In doing so,the parameters of the flow pressure, the flow rate, the pulsability,flow duration and temperature of the repefusate are individually matchedto the patient.

FIG. 4 shows a schematic blood diagram of a further embodiment of theinvention. Sensor unit SEH, provides information obtained from thebodily fluid, more particularly blood, of a patient P. The sensorsignals generated by the sensor unit SEH are forwarded to an analysisunit A which generates an analysis result representing the current stateof the bodily fluid/blood. Based on at least one evaluation criterion,for example, the analysis result is evaluated by an evaluation andcontrol unit A/S. The evaluation and control unit then generates controlor regulating signs for the controlled activation of an operative unitKE which influences the bodily fluid and, in particular, can be composedof at least one of the following sub-units: means for adding at leastone substance to the bodily fluid MS, means of mechanically influencingthe bodily fluid MM and means of thermally influencing the bodily fluid.Each of these means can be combined with joint means. Depending on themeans that can be activated by the evaluation and control unit A/S, thebodily fluid of the patient P undergoes therapeutic manipulation ormodification for the purpose of preventing ischaemic tissue damage.

The device in accordance with the invention is particularly compact and,if possible, designed in a single housing to assure as simple and fullyautomatic operation as possible. The processes of taking the blood,blood analysis, addition of at least one substance to the patient'sblood to obtain “modified blood,” and the reperfusion of the “modifiedblood” take place automatically and in situ, without further knowledgeabout the person to be resuscitated having to be available. The deviceobtains all information for successful reperfusion from the describedsensor data sensors in the form of data from the automatic bloodscreening and sensor-detectable physiological data.

With the benefit of the device in accordance with the invention,controlled whole-body reperfusion can be carried out with which theduration of ischaemia, until irreversible damage to individual organs oreven the entire body, can be considerably increased compared with thecurrent narrow time limits.

LIST OF REFERENCES

-   BE Blood withdrawal means-   BR Blood return means-   BL Blood flow path-   BA Analysis unit-   R Reservoir unit-   D Dosage unit-   A1 Diversion line-   A2 By-pass line-   CIRD Basis module of the controlled integrated resuscitation device-   F Conveying means-   Oxygenator-   G Gas blender-   LF Leukocyte file-   A/K Evaluation/control unit-   WT Heat exchanger-   M Monitoring unit-   S1, S2 . . . . Substance-   Si₁ . . . Control signal-   V1, V2 . . . . Dosage means, valve-   MB Mixing container-   SE₁, SE₂ . . . . Sensors-   SEE₁,SEE₂ . . . . Sensor result-   BAE Blood analysis result-   A Analysis unit-   SEH Sensor unit-   KE Operative unit-   MS Means for adding at least one substance to the bodily fluid-   MM Means of mechanically influencing the bodily fluid-   MT Means of thermally influencing the bodily fluid-   A/S Control Unit

1-26. (canceled)
 27. A device for treating an individual suffering from cardiac or circulatory arrest or from a stroke, comprising blood withdrawal means for application to the individual, an analysis unit directly or indirectly connected to the blood withdrawal means for detecting and providing a blood analysis result including at least one characteristic of the blood, directly or indirectly connected to a return means for application to the individual for delivering a substance to the individual via the return means; and an operative unit comprising at least one reservoir in which at least two substances are stored, a dosage unit combined with the at least one reservoir which, in response to the blood analysis result, selects from the at least two substances at least one substance or produces a mixture of at least two of the substances so that at least one selected substance or the mixture can be introduced into the individual directly or indirectly via the return means.
 28. A device in accordance with claim 27, wherein: the blood withdrawal means is within a blood flow path to the return means; the analysis unit, the at least one reservoir unit and dosage unit are within the blood flow path; and before delivery to the individual via the return means, the at least one selected substance or the mixture can be blended with the blood taken from the individual in order to obtain modified blood.
 29. A device in accordance with claim 28, wherein: at least one conveying means is within the blood flow path to provide regulated flow.
 30. A device in accordance with claim 27, wherein: the analysis unit comprises a plurality of sensors each for recording at least one blood parameter.
 31. A device in accordance with claim 28, wherein: the analysis unit comprises a plurality of sensors each for recording at least one blood parameter.
 32. A device in accordance with claim 29, wherein: the analysis unit comprises a plurality of sensors each for recording at least one blood parameter.
 33. A device in accordance with claim 30, wherein: the analysis unit records at least one blood parameter with at least one of the plurality of sensors selected from the group: pH value, oxygen partial pressure, carbon dioxide partial pressure, potassium content, sodium content, calcium content, base excess, lactate value, glucose content.
 34. A device in accordance with claim 27, wherein: the at least one reservoir stores a plurality of substances which are present in solid, liquid or gaseous form, are stored in separate reservoir chambers, and are supplied in dosed form either individually or in combination by the dosage unit.
 35. A device in accordance with claim 28, wherein: the at least one reservoir stores a plurality of substances which are present in solid, liquid or gaseous form, are stored in separate reservoir chambers, and are supplied in dosed form either individually or in combination by the dosage unit.
 36. A device in accordance with claim 29, wherein: the at least one reservoir stores a plurality of substances which are present in solid, liquid or gaseous form, are stored in separate reservoir chambers, and are supplied in dosed form either individually or in combination by the dosage unit.
 37. A device in accordance with claim 35, wherein: the at least one reservoir stores a plurality of substances which are present in solid, liquid or gaseous form, are stored in separate reservoir chambers, and are supplied in dosed form either individually or in combination by the dosage unit.
 38. A device in accordance with claim 34, wherein: the dosage unit includes at least one mixing container which via a controllable dosing means is connected to individual reservoir chambers, and the at least one mixing container is directly or indirectly connected to the return means through a further controllable dosing means.
 39. A device in accordance with claim 27, wherein: the at least one stored substance is selected from the following substances or substance classes: alkaline or acidic buffer solution, substances affecting the sodium, potassium and/or calcium content, blood-thinning substances, free radical trapping agents, glutamate, aspartame, heart-rhythm-stabilizing substances, substances influencing the leukocyte count, osmotically-active substances, including salts, glucoses, proteins.
 40. A device in accordance with claim 28, wherein: the at least one stored substance is selected from the following substances or substance classes: alkaline or acidic buffer solution, substances affecting the sodium, potassium and/or calcium content, blood-thinning substances, free radical trapping agents, glutamate, aspartame, heart-rhythm-stabilizing substances, substances influencing the leukocyte count, osmotically-active substances, including salts, glucoses, proteins.
 41. A device in accordance with claim 29, wherein: the at least one stored substance is selected from the following substances or substance classes: alkaline or acidic buffer solution, substances affecting the sodium, potassium and/or calcium content, blood-thinning substances, free radical trapping agents, glutamate, aspartame, heart-rhythm-stabilizing substances, substances influencing the leukocyte count, osmotically-active substances, including salts, glucoses, proteins.
 42. A device in accordance with claim 30, wherein: the at least one stored substance is selected from the following substances or substance classes: alkaline or acidic buffer solution, substances affecting the sodium, potassium and/or calcium content, blood-thinning substances, free radical trapping agents, glutamate, aspartame, heart-rhythm-stabilizing substances, substances influencing the leukocyte count, osmotically-active substances, including salts, glucoses, proteins.
 43. A device in accordance with claim 33, wherein: the at least one stored substance is selected from the following substances or substance classes: alkaline or acidic buffer solution, substances affecting the sodium, potassium and/or calcium content, blood-thinning substances, free radical trapping agents, glutamate, aspartame, heart-rhythm-stabilizing substances, substances influencing the leukocyte count, osmotically-active substances, including salts, glucoses, proteins.
 44. A device in accordance with claim 34, wherein: the at least one stored substance is selected from the following substances or substance classes: alkaline or acidic buffer solution, substances affecting the sodium, potassium and/or calcium content, blood-thinning substances, free radical trapping agents, glutamate, aspartame, heart-rhythm-stabilizing substances, substances influencing the leukocyte count, osmotically-active substances, including salts, glucoses, proteins.
 45. A device in accordance with claim 38, wherein: the at least one stored substance is selected from the following substances or substance classes: alkaline or acidic buffer solution, substances affecting the sodium, potassium and/or calcium content, blood-thinning substances, free radical trapping agents, glutamate, aspartame, heart-rhythm-stabilizing substances, substances influencing the leukocyte count, osmotically-active substances, including salts, glucoses, proteins.
 46. A device in accordance with claim 27, comprising: an evaluation and control unit for exchanging data with the analysis unit and the dosage unit in response to a result of the blood analysis generates control signals for controlling the dosage unit.
 47. A device in accordance with claim 46, comprising: a monitoring unit including at least one measuring means for determining at least one parameter of the individual, the at least one parameter being selected from a group of physiological parameters of the individual comprising mean arterial pressure, central nervous pressure, pulmonary artery pressure, oxygen saturation and blood temperature; whereby the monitoring unit is connected to the evaluation and control unit to provide at least a unilateral data exchange.
 48. A device in accordance with claim 27, wherein: the analysis unit comprises a sensor for recording at least one property of the blood of the individual.
 49. A device in accordance with claim 48, wherein: the sensor unit is directly or indirectly connected to the blood withdrawal means.
 50. A device in accordance with claim 48, wherein: the sensor unit records at least one parameter of the blood: pH value, oxygen partial pressure, carbon dioxide partial pressure, potassium content, sodium content, calcium content, base excess, lactate value and glucose content.
 51. A device in accordance with claim 46, wherein: the analysis unit, the operative unit and the evaluation and control unit are portable.
 52. A device in accordance with claim 28, comprising: a by-pass line within the blood flow path between the blood withdrawal means and the return means, a by-pass line directly upstream of the return means through which some of the modified blood returned to the individual may be supplied to the analysis unit, and in response to a comparison by the analysis unit, the dosage unit changes a quantity of the at least one substance supplied into the blood path flow for at least one determinable blood parameter.
 53. A device in accordance with claim 27, comprising: a heat exchanger directly or indirectly connected to the return means.
 54. A device in accordance with claim 53, wherein the evaluation and control unit generates control signals which are transmitted to the conveying means and to the heat exchanger so that the pressure, flow rate and temperature of the at least one substance to be introduced into the individual are selectable.
 55. A device in accordance with claim 28, comprising: an oxygen enrichment and depletion unit for the blood disposed within the blood flow path between the blood withdrawal means and the return means.
 56. A method of treating an individual suffering from cardiac arrest or stroke from which blood is taken which is analyzed in a blood analyzer, a result of the blood analysis being performed by the blood analyzer and at least one evaluation criterion and from at least two stored substances a type and quantity of at least one substance or a substance mixture is determined, comprising: a) adding in dosed form to the blood taken from the individual the at least one substance or the substance mixture which is reperfused into the individual as a perfusion solution to replace the removed blood to obtain modified blood which is reperfused into the individual or b) the at least one substance or the substance mixture is reperfused into the individual as a perfusion solution in place of the removed blood.
 57. A method in accordance with claim 56, comprising: as part of the blood analysis, at least one determined blood parameter is compared with a nominal value and in an event of a quantitatively predeterminable deviation from the nominal value, one substance which influences the blood parameter is selected and added to the removed blood or the perfusion solution in a quantity dependent on the quantitative deviation.
 58. A method in accordance with claim 56, wherein: some of the modified blood is removed to have a repeated blood analysis; and if the at least one determined blood parameter deviates from the nominal value, a correction to a type and/or quantity of the at least one added substance is performed.
 59. A method in accordance with claim 56, wherein: blood withdrawal, blood analysis, adding the at least one substance to the patient's blood or the perfusion solution, as well as the reperfusion of the modified blood or perfusion solution are performed in situ.
 60. A method in accordance with claim 56, wherein: in addition to the blood analysis, at least one physiological parameter of the individual is determined, and in response to both the blood analysis result and the at least one physiological parameter of the individual, a type and quantity of the at least one substance to be added to the removed blood or perfusion solution, and pressure, flow rate and temperature of a modified blood flow or solution to be reperfused into the individual, are selected.
 61. A method in accordance with claim 56, wherein: the reperfusion of the modified blood or the perfusion solution into the patient performed at least two different areas of the body with different reperfusion parameters in terms of pressure, flow rate, temperature and/or perfusion duration.
 62. A method in accordance with claim 20, wherein: blood is taken at a controlled flow rate of at least 1 l/min.
 63. A method in accordance with claim 62, wherein: the controlled flow rate is 6 to 8 l/min. 